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The Norwegian Cerebral Venous Thrombosis Study

Epidemiology, Clinical and Radiological Presentation and Long-term Prognosis of Cerebral Venous Thrombosis in a Norwegian Population (NoCVT)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05021198
Acronym
NoCVT
Enrollment
600
Registered
2021-08-25
Start date
2014-01-01
Completion date
2027-01-31
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cerebral Vein Thrombosis, Cerebral Venous Sinus Thrombosis

Brief summary

The NoCVT study will investigate CVT (2014-2023) in a large Norwegian population (\> 3 millions) using several approaches combining existing health registries, clinical databases and new prospectively collected clinical data to explore epidemiology, risk factors, diagnostics, treatment, and the long-term prognosis of CVT.

Detailed description

A retrospective hospital-based chart review will be conducted at 13 different hospitals covering all four health regions and more than 3 million inhabitants in Norway. These 13 hospitals are Akershus University Hospital, Haukeland University Hospital. Oslo University Hospital (Ullevål), Sørlandet Hospital Kristiansand, Drammen Hospital, St.Olavs Hospital, Nordlandsykehuset Bodø, University Hospital of North Norway, Innlandet Hospital Lillehammer, Tønsberg Hospital, Telemark Hospital (Skien), Molde Hospital and Stavanger University Hospital. A search will be made in the clinical database for patients with the relevant diagnosis of CVT in the period between January 1, 2014, and December 31, 2023. Data from hospital charts will be linked with data from Statistics Norway (SSB), FD-Trygd, and Norwegian Prescription Database (NorPD). Using this combination of clinical data and health registries will make it possible to describe risk factors, clinical and radiological presentation, treatment and short-term outcome in a large Norwegian CVT cohort. Further, data from hospitals will be linked with data from SSB, FD-Trygd, NorPD, Norwegian Patient Registry (NPR) and Cause of Death Registry (DÅR) up to five years after CVT. Using this methodology will make it possible to investigate overall long-term prognosis and outcomes in terms of mortality, health care utilisation, medication use and working situation up to five years after CVT in a large Norwegian cohort. Lastly, a prospective follow-up study will include patients that have been diagnosed with CVT at the NoCVT hospitals during 2019-2023. By combining the collected data from the retrospective hospital chart review with the new follow-up interviews and self-reported questionnaires it will be possible to describe quality of life, vocational outcomes, psychological distress, depression, insomnia and disease-related disability in CVT.

Interventions

None listed

Sponsors

Oslo University Hospital
CollaboratorOTHER
Haukeland University Hospital
CollaboratorOTHER
Drammen sykehus
CollaboratorOTHER
Sorlandet Hospital HF
CollaboratorOTHER_GOV
St. Olavs Hospital
CollaboratorOTHER
Nordlandssykehuset HF
CollaboratorOTHER
University Hospital of North Norway
CollaboratorOTHER
University of Oslo
CollaboratorOTHER
Rigshospitalet, Denmark
CollaboratorOTHER
Hospital de Santa Maria, Portugal
CollaboratorOTHER
Sykehuset Innlandet HF
CollaboratorOTHER
Molde Hospital
CollaboratorOTHER
Helse Stavanger HF
CollaboratorOTHER_GOV
Sykehuset Telemark
CollaboratorOTHER_GOV
Sykehuset i Vestfold HF
CollaboratorOTHER
University Hospital, Akershus
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* A diagnosis of CVT 2014-2023 from the 13 participating primary hospitals

Exclusion criteria

* none

Design outcomes

Primary

MeasureTime frameDescription
Mortality of CVT in a Norwegian populationBaseline, 3 months, 12 months, 24 months and 5 yearsNumber dead vs total number of cases

Secondary

MeasureTime frameDescription
Nursing home after CVTBaseline to five yearsNumber of CVT cases in need for nursing home
Use of anti-coagulation in the long-term after CVTBaseline to five yearsNumber of cases with CVT using anti-coagulation
New diagnosis after CVTBaseline to five yearsType of new diagnosis among CVT cases
Health care utilisation after CVTBaseline to five yearsNumber of new health care system contacts among CVT cases
Re-admission after CVTBaseline to five yearsNumber of new re-admission among CVT cases
Use of anti-platelet therapy in the long-term after CVTBaseline to five yearsNumber of cases with CVT using anti-platelet therapy
Use of painkillers in the long-term after CVTBaseline to five yearsNumber of cases with CVT using painkillers
Use of headache prophylactics in the long-term after CVTBaseline to five yearsNumber of cases with CVT using headache prophylactics
Use of anti-epileptic drugs in the long-term after CVTBaseline to five yearsNumber of cases with CVT using anti-epileptic drugs
New prescriptions after CVTBaseline to five yearsType of new prescriptions among CVT cases
Sick-leave after CVTBaseline to five yearsNumber of cases with CVT on sick-leave
Disability pension after CVTBaseline to five yearsNumber of cases with CVT on disability pension
Headache after CVTBaseline to five yearsType and frequency
Headache-related quality of life after CVTBaseline to five yearsMigraine Disability Assessment Score and Headache Impact Test-6
Seizure/epilepsy after CVTBaseline to five yearsType and frequency
Epilepsy-related quality of life after CVTBaseline to five yearsQuality of Life in Epilepsy Inventory-31
Quality of life after CVTBaseline to five yearsEuroQoL 5
Psychological distress after CVTBaseline to five yearsPatient Health Questionnaire-9 and Hospital Anxiety and Depression Scale
Sleep problems after CVTBaseline to five yearsBergen Insomnia Scale
Use of anti-depressants in the long-term after CVTBaseline to five yearsNumber of cases with CVT using anti-epileptic drugs

Countries

Norway

Contacts

Primary ContactEspen Saxhaug Kristoffersen, MD, PhD
e.s.kristoffersen@medisin.uio.no

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026